Investigator Perspectives on the Development and Use of Oncologic Biosimilars in the Management of Common Cancers


Interview with Hope S Rugo, MD

Track 1: Overview of biosimilar agents
Track 2: Regulatory pathway for the approval of biosimilars
Track 3: Valid short-term endpoints in the clinical development of biosimilars
Track 4: Extrapolating the use of biosimilars; potential combination of biosimilars with other agents
Track 5: Design of the Phase III HERITAGE study evaluating the trastuzumab biosimilar MYL-1401O versus trastuzumab for HER2-positive metastatic breast cancer
Track 6: Efficacy and safety of trastuzumab biosimilars
Track 7: Biosimilars currently approved for cancer in the United States
Track 8: Clinical implications of the HERITAGE trial for patients with HER2-positive metastatic breast cancer
Track 9: Activity and use of filgrastim biosimilars in clinical practice
Track 10: Emerging data with rituximab biosimilars
Track 11: Common myths among oncologists regarding biosimilars
Track 12: Availability of biosimilar agents in the United States and ongoing monitoring for safety

Interview with Gary H Lyman, MD, MPH

Track 1: Rationale for the development of biosimilar agents
Track 2: FDA approval pathway for biosimilars
Track 3: Cost of biologic agents developed for the treatment of cancer
Track 4: Experience with biosimilars in Europe
Track 5: Effects of the cost of cancer therapies on practice patterns
Track 6: Regulatory considerations for biosimilars
Track 7: Manufacturing process for biosimilar products
Track 8: Ongoing monitoring of the efficacy and safety of biosimilars
Track 9: FDA guidance on the requirements for interchangeability
Track 10: Approval of filgrastim and pegfilgrastim biosimilars
Track 11: Preclinical and clinical data supporting the approval of filgrastim
Track 12: Regulatory hurdles for the FDA approval of rituximab biosimilars
Track 13: Potential challenges with incorporating the epoetin alfa biosimilar into clinical practice
Track 14: FDA approval of a trastuzumab biosimilar for HER2-positive metastatic breast cancer and results of the Phase III HERITAGE trial
Track 15: Perspective on the potential integration of trastuzumab and rituximab biosimilars into the treatment algorithm for patients with cancer
Track 16: Clinical role of the bevacizumab biosimilar and safety concerns
Track 17: Perspective on the future of biosimilar agents in cancer care

Interview with Sanjiv S Agarwala, MD

Track 1: Role of biosimilar agents in limiting the cost of cancer therapies
Track 2: Differences between generic drugs and biosimilar formulations
Track 3: FDA review process for biosimilar products
Track 4: Misconceptions among oncologists regarding the efficacy of biosimilars
Track 5: Clinical studies to determine response to biosimilar formulations
Track 6: Regulatory process for attaining the interchangeability designation for biosimilar products
Track 7: Concerns regarding the safety, immunogenicity and cost of biologic agents for patients with cancer
Track 8: Biosimilar agents currently approved by the FDA
Track 9: Development of biosimilars for filgrastim
Track 10: Perspective on healthcare-provider and patient motivation to use biosimilars
Track 11: Availability and ongoing development of biosimilars for rituximab, bevacizumab and cetuximab
Track 12: Importance of counseling patients regarding the regulatory process for biosimilar agents
Sanjiv S Agarwala, MD
Professor and Chief
Hematology and Oncology
St Luke’s Cancer Center
Temple University
Easton, Pennsylvania
Gary H Lyman, MD, MPH
Senior Lead
Healthcare Quality and Policy
Hutchinson Institute for Cancer Outcomes Research
Fred Hutchinson Cancer Research Center
Professor of Medicine
University of Washington School of Medicine
Seattle, Washington
Hope S Rugo, MD
Professor of Medicine
Breast Oncology and Clinical Trials Education
University of California, San Francisco
Helen Diller Family Comprehensive Cancer Center
San Francisco, California
Neil Love, MD
Research To Practice
Miami, Florida